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Initia Total Hip System GMH02-100004

by Kyocera Medical Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04580810056191 UDI-DI Date17 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Initia Total Hip System
Generic Name
Metal-on-polyethylene total hip prosthesis
Model / Reference
GMH02-100004
Description
"INITIA SHELL 46-7H Size: φ46MM O.D. Type: 7 HOLE"
Primary DI / UDI-DI
04580810056191
FDA Product Code
LPH
GMDN Term
Metal-on-polyethylene total hip prosthesis
Device Class
Class II
Regulation Number
888.3358
GUDID distribution status
In Commercial Distribution

Other devices from Kyocera Medical Corporation

See all devices from Kyocera Medical Corporation →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No